• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Lipid Disorders

• Cardiology & Cardiovascular Medicine
• Cardiology Clinical Trials
• Interventional Techniques & Devices
• Lipid Disorders

Peripheral artery disease (PAD) is often accompanied by intermittent claudication, which may lead to functional disability. Supervised exercise therapy (SET) is the recommended first-line therapy for intermittent claudication. The Endovascular Revascularization and Supervised Exercise for Claudication study [ERASE] sought to determine whether endovascular revascularization (EVR) with SET led to greater improvement in walking distance and claudication symptoms than SET alone.

Farzin Fakhry, MSc, Erasmus Medical Center, Rotterdam, The Netherlands, presented the results from the ERASE trial. The study, conducted at 10 sites in The Netherlands, enrolled patients with stable (>3 months) intermittent claudication, a vascular obstruction >50% at the aortoiliac and/or femoropopliteal level, a target lesion suitable for EVR, no ambulation limitations attributed to other conditions, and no prior treatment (including exercise therapy). Patients were randomized to EVR plus SET (n=106) or SET alone (n=106). EVR consisted of balloon angioplasty of aortoiliac and/or femoropopliteal lesion with selective stenting. SET sessions lasted 1 hour and were administered by trained physical therapists. Patients had SET sessions 2 to 3 times per week during the first 3 months, 1 to 2 times per week during Months 3 to 6, and once every 4 weeks for Months 6 to 12.

The primary endpoint was the maximum walking distance on the graded treadmill test (Gardner protocol, 30 minutes). Secondary endpoints included pain-free walking distance (Gardner protocol, 30 minutes), ankle brachial index (ABI) at rest and after treadmill walking, self-reported quality of life (QoL) scores (VascuQoL, Short-Form 36 Health Survey [SF-36] rating score, and EuroQoL), leg amputations, and secondary interventions.

In the EVR plus SET group, 94% of patients completed the 12-month study versus 92% in the SET group. After 12 months, the EVR plus SET group had significantly greater improvement in maximum walking distance than the SET group, with a mean difference of 282 m (99% CI, 60 to 505 m; p=0.001). Significant improvements were also noted in pain-free walking distance, resting and postexercise ABI, the disease-specific VascuQoL, and the SF-36 physical functioning measure (all p<0.01). In addition, there was a significantly lower proportion of patients requiring interventions in the EVR plus SET group (p<0.01). Fakhry concluded that the combination of EVR and SET led to improved walking distance and QoL for patients with intermittent claudication compared with SET alone.

Discussant Mary McGrae McDermott, MD, Northwestern University, Chicago, Illinois, USA, pointed out several limitations of the ERASE study. The benefits seen in the EVR plus SET group were greatest early in the study, and therefore may diminish over time. Additionally, because the primary endpoint, treadmill walking, is not representative of walking in real life, the 6-minute walk test and physical activity results may be more clinically relevant if measured in an uncontrolled environment. Dr. McDermott also noted that the amount of exercise in the study was considerably less frequent than current recommendations (3 times per week); raising the hypothesis that less of a difference may have been seen with a more intensive SET program. Lastly, reimbursement and accessibility issues could potentially complicate SET implementation. Dr. McDermott encouraged researchers to devise treatments that take these obstacles into account.

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